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Terminated

PANTERA Proximal Humerus Fracture Plate System

FDA Recall Z-0599-2020 · Posted None

Recalling FirmToby Orthopaedics, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2013-06-05
Date Terminated2020-09-16
Product Quantity1700 devices

Reason for Recall

Potential suture clip breaking during a humerus fixation surgery.

Firm Action

Beginning on 06/05/2013 the firm notified their direct consignees of the change in the instructions for use (IFU). On 10/11/2019, the firm followed up with the direct accounts (distributors) to reach out to the users to inform them of the change.

Root Cause

Labeling design

Distribution Pattern

Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081608PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)Toby Orthopaedics, LLC · 2008-12-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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